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On July 2, British drug maker GlaxoSmithKline agreed to plead guilty and pay a $3 billion fine for its off-label marketing of three drugs and for its failure to comply with the FDA’s post-marketing reporting requirements for one of its drugs

Those of us practicing law or working in device regulatory compliance in the United States are not alone in our quest to better understand the mood and direction of the Centers for Device and Radiological Health (CDRH